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510(k) K834190

JAKOBI SURG. INSTRUMENTS #8 15 by Imm Enterprises , Ltd. — Product Code EMH

K834190 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "JAKOBI SURG. INSTRUMENTS #8 15". The FDA issued a decision of Substantially Equivalent on March 6, 1984. The device falls under product code EMH (Forceps, Rongeur, Surgical), a Class I device regulated under 21 CFR 872.4565. Imm Enterprises , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1984
Date Received
November 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Rongeur, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Imm Enterprises , Ltd.

  • K841387 — WESTON RECTAL SNARE (May 9, 1984)
  • K841386 — KOLLMANN URETHRAL DILATOR (May 9, 1984)
  • K840311 — CAT. 7-EAR, NOSE & THROAT DEVICES (May 9, 1984)
  • K840304 — CATEGORY 17-MICROBIOLOGY DEVICES (May 1, 1984)
  • K840305 — CATEGORY 1 CIRCULATORY SYSTEM DEVICE (April 23, 1984)
  • K840318 — CAT. 14-CLINICAL TOXIOLOGY DEVICES (April 23, 1984)
  • K840312 — CAT. 8 DENTAL DEVICES (April 5, 1984)
  • K834171 — OP-CON SURG. INSTRUMENT #3 (April 4, 1984)
  • K834191 — JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 (March 22, 1984)
  • K834192 — JAKOBI SURG. INSTRUMENTS #3 21/22/24 (March 22, 1984)

Other clearances for product code EMH

  • K890255 — BONE RONGEUR, SINGLE-ACTION (January 27, 1989)
  • K890256 — BONE RONGEUR, DOUBLE-ACTION (January 27, 1989)
  • K854887 — MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT (February 28, 1986)
  • K851710 — 586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC (June 11, 1985)
  • K834366 — SURGICAL INSTRUMENTS & ACCESSORIES (February 27, 1984)
  • K821358 — MODIFIED RONGEURS FOR SPINAL & ORTH. S. (May 28, 1982)
  • K771522 — FORCEPS, STYLE #849 (August 16, 1977)

FDA data resources